Upload
digital-health-coalition
View
217
Download
0
Embed Size (px)
Citation preview
8/2/2019 DHC Q&A With Darshan Kulkarni (FDALawyers)
1/3
Iefeyd k Cbdkyc Ahdk e y ehl
Idrqcdl Nkndrle
LHYB= Yceq el`hrjdyehl ihbq lhyahlqyeyyb kbfdk dipeab, Yh cdpb ycb
Nkndrle Kdv @erj #@erj% ibybrjelb e`
ycb dipeab eq dwwrhwredyb `hr uh+ uhjqy ydkn yh d kdvubr dy ycb @erj dli
arbdyb dl dyyhrlbu*akebly rbkdyehlqcew,D rbably adqb el Dqyrd k ed#Dqyrd k edl Ahjwbyey ehl dliAhlqjbr Ahjjeqqehl p Dk kbrfuWdycvdu Wyu Kyi% qcbi qhjbk efcy hl chv ycb ahry ycbrbp ebvq rbqwhlqeo e k e yu dli ahlyrh kh` cbdkyc dli jbieadk ahlyblyhlk elb, Dlu elqefcyq `hrahjwdlebq el ycb RQ8Ibqweyb ycb `day ycdy Dqyrdkedl
Ahjwbyeyehl dli Ahlqjbr Ahjjeqqehl
p Dkkbrfu Wdycvdu Wyu Kyieq d lhl*RQ
adqb+ ey wrhpeibq dl bsdjwkb h` d
rbdqhldokb ahry yruelf yh dwwku
ibadibq hki wrelaewkbq h`
`hhi(irf(jbieadk ibpeab kdv yh dl
bpbr*acdlfelf vhrki h` Elybrlby
ybaclhkhfu, Ycb Ahry irbv d fhhiodkdlab dli odqbi eyq hwelehl hl ycb
qejwkb wrelaewkbq h` vcbycbr Dkkbrfu
Wdycvdu Wyu Kyi, nlbv hr qchki cdpb
nlhvl h` eldaardyb hr jeqkbdielf
qydybjblyq dli vcbycbr ycbu yhhn
dwwrhwredyb qybwq yh `es ycbqb
eldaardyb dli(hr jeqkbdielf
qydybjblyq hl wdfbq ycdy vbrb libr
ycber ahlyrhk,
El`hrjdk ieqaqqehlq dli lhl*oelielf
ieqaqqehlq veyc RQ qydnbchkibrq
elakielf ke`b qaeblabq ahjwdlebq+
wrhpeibrq+ dli ycb fhpbrljbly qbbj yh
rbqky el qejekdr pebvq, Ycb @ID cdq+jkyewkb yejbq+ elieadybi ycdy ycbu
ahlqeibr ycb Elybrlby yh ob mqy
dlhycbr acdllbk h` ahjjleadyehl
qombay yh ycb qdjb rkbq dq hycbr
acdllbkq, _bqkydlyku+ vcekb ycbrb drb
lh ib`eleyepb pebvq hl ycb eqqb+ ycb
iyu yh ahlyrhk eldaardyb dli(hr
jeqkbdielf qydybjblyq kenbku bseqyq+ dli
ahjwdlebq vhki kenbku ob bswbaybi yh
ahlyrhk wdfbq,
Dlu ahlabrlq dohy yceq adqb8Eq ycb wrbjeqb hr elybrwrbydyehl` kdvbi el uhr hwel ehl8Dq dwwkebi yh RQ kdv= Ycbrb drb d `bv
qbwdrdyb ahlabrlq ycdy adl fepb d ke`b
qaeblabq ahjwdlu wdqb, Qwbae`eadkku+
ycb ahry cbki ycdy d ke`b qaeblabq
ahjwdlu eq rbqwhlqeokb `hr ycb dayehlq
h` ahlqjbrq dli wdyeblyq dli
b``bayepbku dayq el ycber wkdab e` ey `dekqyh rbjhpb whyblyedkku jeqkbdielf
ahlybly, Yceq hwblq w d rdlfb h`
eqqbq elakielf chv #4% Chv h`ybl
jqy d ahjwdlu rbpebv ycb pdrebyu h`
vboqeybq yh ob dokb yh ibjhlqyrdyb
ycdy ey ihbq lhy veqc yh day dq hlb h`
eyq ahlqjbrq #?% Eq ycbrb d iyu yh
Ir, Nkndrle eq ycb Wrelaewdk Dyyhrlbu dy ycb Nkndrle Kdv @erj, Cb `haqbq hl qyrdybfea ahjwkedlab dli
ycber rbfkdyhru dli ahlqbkelf lbbiq, Ceq bsyblqepb bswbreblabq jdldfelf ycb lbbiq h` fkhodk ke`b
qaeblabq ahjwdlebq dli ycber qbrpeab wrhpeibrq elakielf Ahlyrday Jdl`dayrelf Hrfdle}dyehlq+ Ahlyrday
_bqbdrac Hrfdle}dyehlq dli dipbryeqelf dli yrdelelf ahjwdlebq, Ir, Nkndrle cdq dqqeqybi ceq akeblyq el
jbbyelf d pdrebyu h` kbfdk dli rbfkdyhru lbbiq elakielf ard`yelf rbqwhlqbq yh @ID 931q+ @ID rbadkkq+
wrhjhyehldk dli ahjwkedlab rbpebv dli akeleadk yredk lbfhyedyehlq, Obqeibq ceq bswbreblab dq dl dyyhrlbu+
Ir, Nkndrle eq d wcdrjdaeqy+ Dqqhaedyb Wrh`bqqhr+ dli dychr, @hkkhv cej hl Yveyybr G@IDKdvubrq,
8/2/2019 DHC Q&A With Darshan Kulkarni (FDALawyers)
2/3
Iefeyd k Cbdkyc Ahdk e y ehl
ahrrbay jeqel`hrjdyehl8 Hr eq jbrbku
rbjhpelf ycb ahlybly eldibtdybku dli
b``bayepbku ahlqyeyybq qoqareoelf yh
qac hwelehlq8
Dq fkhodk jky e*ldy ehldkahjwdlebq qbbn yh wdry ea ewdybel dl elarbdq elf ku f khod k dliahllbaybi ief eyd k vhr ki + chvadl ahjwdlebq yceln dohyfbhfrdwcea ohlidrebq # el dkbfd k qblqb% vcbl ycb Elybrlbyybliq yh pebv ahlybly `rhj ycbwbrqwbay epb h` kdlfdfb yhidu8Ey eq elarbdqelfku ie``eaky yh ahlyrhk
vcdy wdyeblyq qbb hl ycb Elybrlby,Yceln dohy uhr dieblab+ yceln dohy
vcdy uh adl qdu+ dli ahlqeibr ycb
`day ycdy wdyeblyq `rhj darhqq ycb
fkhob vekk kenbku ob dokb yh daabqq ycb
vhrn ycdy uhr ahjwdlu eq wyyelf hy
errbqwbayepb h` vcbrb el ycb vhrki ycbu
drb, Bdac ahlyru cdq ie``brbly kdvq
dli ey eq cblab ejwhrydly e` whqqeokb yh
kejey daabqq yh pebvbrq `rhj ycb
qwbae`ea ahlyru el tbqyehl,
Dkybrldyepbku d ahjwdlu+ e` lbabqqdru+
jqy dwwrhwredybku ib`elb ycb ahlyru
obelf ydrfbybi #bpbl e` hycbr ahlyrebq
jdu whyblyedkku daabqq ycb qeyb,%
Ycq+ ey eq h`ybl dipdlydfbhq yh
ahlqeibr cdpelf d vbo*qb whkeau dli
jdnelf ey daabqqeokb, Ibaeib vceac qeybq
uh vekk dihwy dli jhleyhr+ ycb
bsybly yh vceac uh vekk jhleyhr ycbqb
qeybq+ dli ycbl cdpb dwwrhwredyb
wrhabqqbq yh rbpebv,
Ycbrb drb d `bv adqbq vhrn elfycrhfc ycb RQ kbfdk quqybj+vceac ve k k cdpb q efl e ` eadlyejwk eady ehlq `hr h`` kdobk dliycb doe k eyu h` ahjwdlebq yhahjjleadyb veyc wdy eblyq+
wrh`bqq ehld kq + dli ycb wo k ea dykd rfb, Chv vhki uhacdrdaybr e}b ycb whqq eo kb ejwdayh` ycbqb adqbq yh ycb `yrb h`i ef eyd k wcdrjdabyead kjdrnby elf8Ycb `hrycahjelf ibodyb hl h``*kdobk
ieqaqqehlq eq kenbku yh cdpb d
qefle`eadly dli wbrjdlbly ejwday hl
wcdrjdabyeadk jdrnbyelf el fblbrdk+
dli iefeydk dli el*wbrqhl jdrnbyelf el
wdryeakdr, Ahjwdlebq cdpb obbl
cbqeydly yh fby hl qhaedk jbied
obadqb ycb whyblyedk `hr h``*kdobk
ieqaqqehlq vdq qefle`eadlyku wkdadybi
ou ycb feidlab ycdy ycb @ID rbablykuwy hy hl lqhkeaeybi h``*kdobk
ieqaqqehlq, Lbpbrycbkbqq+ ycb wblielf
ibaeqehlq jdu dii `rycbr abrydelyu yh
dl eliepeidk ahjwdluq ibaeqehl*jdnelf
wrhabqq dli whyblyedkku wrhpeib
jdrnbyelf dli jbieadk biadyehl
ibwdryjblyq veyc ycb doekeyu yh
ahjjleadyb obyybr veyc wdyeblyq dli
wrhpeibrq,
E ` uh cdi ycrbb k elbq yh qjw ycb ib` el ey ehl h` ahlyrhk dlirbqwhlqeo e k e yu h` cbd kyc dlijbieadk ahlybly hlk elb `rhjycb jdl`dayrbr wbrqwbay epb chv vhki uh ih ey8E` uh veqc yh dihwy d qeyb+ uh jqy
ahlyrhk ycb ahlybly, E` uh ahlyrhk ycb
ahlybly+ uh jqy blqrb eyq daardau,
Uh jqy qb dwwrhwredyb jbdqrbq yh
biadyb dli bjwhvbr ycb ahrrbayeliepeidkq yh ahl`erj ycdy ycbu adl
wrhwbrku jhleyhr dli ahlyrhk ycb qeyb
`hr uh,
8/2/2019 DHC Q&A With Darshan Kulkarni (FDALawyers)
3/3
Iefeyd k Cbdkyc Ahdk e y ehl
Dlu dipeab yh d fblbrd k ahlqbkyruelf yh fby ycber cbdi drhliycb `yrb h` ief eyd k cbdkyc84, Ydkn yh uhr qydnbchkibrq dli
ibaeib uhr kbpbk h` reqn*ydnelf doekeyu,
?, Ihly yru yh ob uhr ahjwdluq
ahjwkedlab h``eabr, Uhr rhkb eq yh
dwwrhwredybku rbwrbqbly uhr ahjwdluq
elybrbqyq #elakielf eyq jdrnbyelf
elybrbqyq%, Ahlpbrqbku+ ycb rhkb h` d
ahjwkedlab h``eabr eq lhy yh khhn dy ycb
obqy elybrbqyq h` ycb ahjwdlu `rhj d
jdrnbyelf wbrqwbayepb oy `rhj d
ahjwkedlab wbrqwbayepb, Ycbrb eq d
whyblyedk ahl`keay h` elybrbqy+ dli ycbIHM vhki kenbku lhy khhn neliku hl uh
hpbrrkelf ycb ahjwkedlab h``eabr,
1, Ybaclhkhfu eq acdlfelf> kby
jdrnbyelf feib uh hl ycb ierbayehl
h` ybaclhkhfu+ oy qb uhr hvl fy
elqyelay hl ycb dwwrhwredyblbqq h` eyq
qb dli ycb qeydoekeyu h` ycb jbqqdfb
`hr uhr wdyeblyq,
Vcdy drb uhr `dphreyb cbdkycdli jbiead k q eybq yhidu8Jbiqadwb,ahj dli Irfq,ahj,
Vcdy ybaclhkhfu ahjwdlebq ihuh jhqy dijerb8Dwwkb `hr eyq doekeyu yh ordli dli
Fhhfkb `hr eyq ibqerb yh ellhpdyb,
Fhhfkb cdq d wrhfrdj ycdy blahrdfbq
ellhpdyehl dli dkkhvq ey bjwkhubbq yhqwbli w yh ?7" h` ycber rbqhrabq hl
wbrqhldk wrhmbayq+ vceac bpblydkku jdu
ibpbkhw elyh ceyq kenb Fjdek,
Vcdy ybaclhkhfu ibpeab ih uhjhqy dijerb8Ycb Fhhfkb bubfkdqqbq
Vcdy ybaclhkhfu dipdlabjblyih uh jhqy dijerb8Dl hkieb oy d fhhieb= Abkk wchlbq, E
adl ob dluvcbrb el ycb vhrki+ dli E
dj dkvduq rbdacdokb,Vcdy ybaclhkhfu dipdlabjblyih uh jhqy ibqweqb8Ybsy jbqqdfelf, Wkbdqb ydkn yh jb
vcbl uh vdly yh cdpb d ahlpbrqdyehl,
Vcbl eq ycb kdqy y ejb uh vblyh`` ycb frei `hr dy kbdqy ?9chrq8E h`ybl `eli juqbk` fhelf h`` ycb frei
hl ju `rbtbly yrewq yh Elied, Ey eq
lqbyykelf yh qydry veyc+ oy uh obfel
blmhuelf wbhwkb dfdel d`ybr uh fby
qbi yh ycb eibd ycdy uhr bjdekq
drbly ahjelf ycrhfc ejjbiedybku,